(68 days)
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Unknown
The summary mentions "precise spatial registration" and "image processing" but does not explicitly state the method used. While AI/ML is a common approach for image registration, the summary lacks specific details about the algorithm or any mention of training/testing data, which are typical indicators of AI/ML.
No
The device is a software system for image registration used for diagnosis and treatment planning, not for delivering therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The resulting image sets can then be used for diagnosis".
Yes
The device is described solely as a "software system" and its function is image processing, which is a software-based task. There is no mention of any accompanying hardware components.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the resulting image sets can be used for diagnosis. This is a key characteristic of an IVD.
- Function: The software performs "precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician." While image processing itself isn't always IVD, when it's used to provide information for diagnosis, it falls under the IVD umbrella.
While the description doesn't explicitly state it analyzes biological samples (the "in vitro" part of IVD), the FDA's definition of IVD is broad and includes devices used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. In this case, the "specimens" are the image sets derived from the patient's body.
Therefore, because the device provides information used for diagnosis, it aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This submission describes a software system that provides precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
K970623
APR 28 1997
Summary of Safety and Effectiveness ImMerge™ Image Correlation System
Surgical Navigation Technologies 】. Company: 530 Compton St. Broomfield, CO 80020 (303) 439-9709
- Product Name: ImMerge™ Image Correlation System II.
- III. This submission describes a software system that provides precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy.
- I V. The ImMerge™ Image Correlation System was shown to be substantially equivalent to to other commercially available image correlation systems. Evidence of the substantial equivalence was provided.